RecruitingPhase 1NCT06778863

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.

Checked against the public recordLast updated Feb 13, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations21
SponsorClasp Therapeutics, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Clasp Therapeutics, Inc.
Interventions being studied
Drug: CLSP-1025
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: * Patients must be at least 18 years of age at the time of signing the informed consent. * Patients must be willing and able to provide written informed consent * Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists * Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test * Patients must be HLA-A\*02:01 positive by central assay * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment * Adequate hematological, renal and hepatic function * Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation Key Exclusion Criteria: * Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation * Patients who have received other p53 R175H-directed therapies * Patients who have not fully recovered from adverse events due to previous anticancer therapies * Patients with active infection requiring systemic antimicrobial therapy * Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission. * Known active central nervous system metastases and/or carcinomatous meningitis

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HonorHealth Research InstituteScottsdale, Arizona
  • The University of Arizona Cancer CenterTucson, Arizona
  • USC - Norris Comprehensive Cancer CenterLos Angeles, California
  • University of California Davis Comprehensive Cancer CenterSacramento, California
  • University of California San FranciscoSan Francisco, California
  • University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
  • The University of Chicago Comprehensive Cancer CenterChicago, Illinois
  • University of Kentucky Markey Cancer CenterLexington, Kentucky
  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
  • Hackensack University Medical CenterHackensack, New Jersey
  • NYU Langone HealthNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2026. Always confirm current availability with the study team.

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